Palbocent 125

Warnings & Precautions

Neutropenia Neutropenia was the most frequently reported adverse reaction in Study 1 (PALOMA-2), at 80%, and in Study 2 (PALOMA-3), at 83%. A Grade 3 fall in neutrophil counts was reported in 66% of patients receiving Palbociclib plus letrozole in Study 1, and in 66% of patients receiving Palbociclib plus fulvestrant. In Study 1 and 2, the median time to the first episode of neutropenia of any grade was 15 days, and the median duration of Grade 3 neutropenia was 7 days. Check complete blood counts before starting Palbociclib and at the beginning of each cycle, as well as on Day 15 of the first 2 cycles, and whenever clinically needed. Dose changes or a delay in treatment cycles are recommended for patients who develop Grade 3 or 4 neutropenia. Febrile neutropenia was reported in 1.8% of patients exposed to Palbociclib in Studies 1 and 2, and one death due to neutropenia was seen in one of the studies. Physicians should tell patients to report any fever promptly. Interstitial Lung Disease (ILD)/Pneumonitis Severe, life-threatening or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitors, including Palbociclib when it is taken with endocrine therapy. Across the clinical trials (PALOMA-1, PALOMA-2, PALOMA-3), 1.0% of patients treated with Palbociclib had ILD/pneumonitis of any grade, 0.1% had Grade 3 or 4, and no fatal cases were reported. More cases of ILD/pneumonitis have been seen after the medicine came on the market, and some of these were fatal. Monitor patients for pulmonary symptoms that point to ILD/pneumonitis, such as hypoxia and cough. If a patient has new symptoms and ILD/pneumonitis is suspected, interrupt Palbociclib immediately and evaluate the patient. Permanently discontinue Palbociclib in patients with severe ILD or pneumonitis. Embryo-Fetal Toxicity Based on findings from animal studies and its mechanism of action, Palbociclib can cause fetal harm when given to a pregnant woman. In animal reproduction studies, giving Palbociclib to pregnant animals resulted in embryo-fetal toxicity at maternal exposures that were 4 times the human clinical exposure, based on area under the curve (AUC). Pregnant women should be told about the potential risk to a fetus. Females of reproductive potential should be advised to use effective contraception during treatment with Palbociclib and for at least 3 weeks after the last dose.